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Lead Auditor

Lead Auditor Job We re HiringLNE/G-MED is an established, 100-year old company that provides independent certification services, product testing and training for regulatory compliance and quality assurance professionals worldwide. Due to rapid growth in our North American office, the company is seeking Lead Auditors, both on a contract and permanent basis. For the following fields:

  • Certification of Quality Management Systems according to ISO Standards (according to ISO 9001, ISO 13485, etc.)
  • Certification for the CE Marking of Medical Device (MDD, AIMDD, IVDD)
  • Certification for access to the Canadian market (CMDCAS)
  • MDSAP

Take advantage of the opportunity to work on the frontier of medical device innovation and have a finger on the pulse of the ever-changing international life sciences regulations.

Job description

Responsibilities

The permanent responsibilities of a Lead Auditor include, but are not limited to the following:

  • Performing audits (onsite, documentary) as auditor or lead auditor relating to ISO 9001, ISO 13485, etc. standards in the Medical Device sector
  • Performing audits as auditor or lead auditor related to the European Medical Devices Directives (CE marking) and/or to the Canadian Regulations (CMDCAS program)
  • Performing audits as auditor or lead auditor in the framework of the MDSAP program
  • Maintaining a clear correspondence with clients and providing clients and in-house teams with all data needed to facilitate the communication and satisfy the clients’ needs.
  • Interacting with in-house Certification Project Managers, experts’ teams, and quality managers in order to meet with the regulatory and internal processes.

Minimum Requirements

  • Minimum 4-year degree in a life science (Biology, Chemistry, Physics, etc.) or Engineering (Electrical, Mechanical, Bioengineering, etc.)
  • 4 years of experience in the medical devices industry in R&D, design, manufacturing, regulatory, or quality. Preferably in the In Vitro Diagnostic or active medical devices fields
  • Experience auditing medical device manufacturers and their subcontractors
  • Qualified auditor for ISO 13485, preferably also qualified for MDD/AIMDD/IVDD auditing by a notified body
  • Strong organizational skills (demonstrated ability to prioritize and focus to meet deadlines) and result-oriented
  • Excellent written and verbal communication skills with ability to summarize, understand, relate, and explain technical content for specific audiences
  • Team-oriented with an open-mind to concepts and suggestions from others
  • Proficient in MS Office applications
  • Fluent in English usage, spelling, grammar, and punctuation.
  • Ability to travel domestically

Key Attributes

  • Strong organizational skills (demonstrated ability to prioritize and focus to meet deadlines)
  • Strong results-oriented and self-driven person
  • Ability to follow procedures and instruction
  • Excellent written and verbal communication skills, with ability to summarize technical content for specific audiences
  • Ability to understand, relate, and explain technical topics in a tactful manner
  • Ability to coordinate with a team
  • Open-minded, i.e; willing to consider alternative ideas or points of view
  • Self-reliant, i.e; acts and performs functions independently while interacting effectively with others,
  • Proficient in MS Office applications
  • Fluent in English

Preferred (Optional)

  • Clinical or medical experience
  • Excellent public speaker
  • Additional languages: French, Spanish

LNE/G-MED North America is an Equal Employment Opportunity.

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Combo Training ISO13485 MDSAP

Questions?

We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

   1-301-495-0477

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clientsWe're Hiring!

Due to rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

Training LNE G MED

Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

2 days course 

Click here to Register